(44 days)
The Vega™ SPAN™ Spinous Process Plate System is a posterior non-pedicle supplemental fixation system intended for use in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to the spinous process for the purpose of achieving supplemental fusion for the following indications: spondylolisthesis, trauma (fracture or dislocation), tumor, or degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies). The device is intended for use with bone graft material and is not intended for stand-alone use.
The Vega™ SPAN™ Spinous Process Plate System consists of plates of varying length and hub diameters, set screws, and instruments required for implantation. Spikes are present on the sides of the plate that interface with the spinous process to restrain the plate from rotating post-operatively. The device is offered with varying lengths and hub diameters to accommodate anatomical needs. Set screws are used to secure the two sides of the device into the final compressed and implanted construct. System components are supplied non-sterile, are single use and are fabricated from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F 136.
The provided text describes the regulatory clearance for the Vega™ SPAN™ Spinous Process Plate System, not an AI/ML powered medical device. Therefore, the information requested about acceptance criteria and studies related to AI/ML device performance (such as sample sizes for test/training sets, expert adjudication, MRMC studies, and ground truth establishment) is not applicable or available in the given document.
The document focuses on demonstrating substantial equivalence to predicate devices through a 510(k) submission, primarily relying on mechanical testing and comparison of technological characteristics.
Here's the relevant information based on the provided text, aligned with the spirit of your request regarding device performance and acceptance:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Demonstration of Equivalence) | Reported Device Performance (Method Used) |
|---|---|
| Equivalence in Indications for Use | Compared to predicate devices (K073278, K071877, K050675) |
| Equivalence in Function | Compared to predicate devices |
| Equivalence in Operating Principles | Compared to predicate devices |
| Equivalence in Materials (Titanium alloy (Ti-6AL-4V ELI) conforming to ASTM F 136) | System components are fabricated from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F 136. |
| Performance in Static Compression | Mechanical testing per ASTM F1717 |
| Performance in Dynamic Compression | Mechanical testing per ASTM F1717 |
| Performance in Torsion | Mechanical testing per ASTM F1717 |
2. Sample size used for the test set and the data provenance:
- Not Applicable. This device’s clearance was based on mechanical testing, not a test set of data with human subjects or images requiring "data provenance" in the context of an AI/ML device. The "test set" here refers to the physical devices undergoing mechanical tests. The specific number of devices tested is not detailed in this summary, but mechanical testing typically involves a statistically significant number of samples to demonstrate consistency.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. Ground truth, in the context of AI/ML, refers to clinically validated diagnoses or classifications. For this device, "ground truth" relates to the performance standards defined by ASTM F1717 for mechanical properties, which are established engineering standards, not expert clinical consensus.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods are used to establish ground truth in studies involving human interpretation or clinical outcomes. This study involved mechanical testing against established standards.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. An MRMC study was not conducted as this is a physical medical device, not an AI/ML diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an algorithm-only device. The "standalone" performance here refers to the device's mechanical integrity as tested in a laboratory setting. The results of these tests demonstrated the device meets mechanical performance criteria as defined by ASTM F1717.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the mechanical testing, the "ground truth" was established engineering standards, specifically ASTM F1717, which define acceptable static and dynamic compression and torsion performance for spinal implant devices.
8. The sample size for the training set:
- Not Applicable. This is not an AI/ML device, so there is no concept of a "training set" in the machine learning sense.
9. How the ground truth for the training set was established:
- Not Applicable. As above, no training set was used.
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.